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Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study (ISAR)

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ClinicalTrials.gov Identifier: NCT01152892
Recruitment Status : Active, not recruiting
First Posted : June 29, 2010
Last Update Posted : January 26, 2016
Sponsor:
Collaborators:
Else Kröner Fresenius Foundation
AIT Austrian Institute of Technology GmbH
Ludwig-Maximilians - University of Munich
FH Aachen, University of applied sciences
Information provided by (Responsible Party):
PD Dr. Christoph Schmaderer, Technische Universität München

June 28, 2010
June 29, 2010
January 26, 2016
April 2010
May 2019   (Final data collection date for primary outcome measure)
Mortality of all causes [ Time Frame: 24 months ]
24 month follow up
Mortality of all causes [ Time Frame: 24 months ]
Complete list of historical versions of study NCT01152892 on ClinicalTrials.gov Archive Site
  • Incidence of cardiovascular events [ Time Frame: 24 months ]
    24 month follow up
  • Blood pressure drops within a dialysis session [ Time Frame: 24 months ]
    24 month follow up
  • Incidence of infections requiring antibiotic treatment [ Time Frame: 24 months ]
    24 month follow up
  • Incidence of shunt thrombosis [ Time Frame: 24 months ]
    24 month follow up
  • incidence of death and hospitalization due to infection [ Time Frame: 24 months ]
    24 month follow up
  • Incidence of cardiovascular events [ Time Frame: 24 months ]
  • Blood pressure drops within a dialysis session [ Time Frame: 24 months ]
  • Incidence of infections requiring antibiotic treatment [ Time Frame: 24 months ]
  • Incidence of shunt thrombosis [ Time Frame: 24 months ]
Not Provided
Not Provided
 
Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study
Risk Stratification in End Stage Renal Disease (ISAR)
The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Serum
Non-Probability Sample
patients with end stage renal disease treated with chronic hemodialysis
  • End Stage Renal Disease
  • Chronic Kidney Disease
  • Cardiovascular Event
  • Sudden Cardiac Death
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
400
May 2020
May 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 or older
  2. End-stage renal disease (ESRD) and receiving maintenance hemodialysis

Exclusion Criteria:

  1. Any clinically significant infection.
  2. pregnancy
  3. history of malignant disease with a prognostic life expectancy less than 24 months
  4. missing of written and informed consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01152892
ISAR ESRD 01 2010
No
Not Provided
Not Provided
PD Dr. Christoph Schmaderer, Technische Universität München
Technische Universität München
  • Else Kröner Fresenius Foundation
  • AIT Austrian Institute of Technology GmbH
  • Ludwig-Maximilians - University of Munich
  • FH Aachen, University of applied sciences
Principal Investigator: Christoph Schmaderer, M.D., PD study chief investigator and head of the nephrological laboratory at the department of nephrology of the Klinikum rechts der Isar of the Technical University of Munich
Technische Universität München
January 2016